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A Community Cardiovascular Disease Risk Reduction Program in Older Adults Engaged in Congregate Nutrition Services (CAN-DO)

A Community Cardiovascular Disease Risk Reduction Program in Older Adults Engaged in Congregate Nutrition Services (CAN-DO)

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07168044
Acronym
Can-Do
Enrollment
50
Registered
2025-09-11
Start date
2025-10-21
Completion date
2026-09-30
Last updated
2025-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Risk, Cardiovascular Risk Reduction

Keywords

Community health worker, cardiovascular risk reduction

Brief summary

Investigators plan to test the effect of a Cardiovascular disease (CVD) risk reduction program targeted to improve nutrition and self-management of chronic cardiovascular conditions among older adults participating in congregate meal programs offered at community senior centers.

Detailed description

This project proposes utilizing community health workers (CHWs) to deliver targeted health programming to participants in congregate meal programs as part of the Title III-C Nutrition Services Program. By integrating a targeted intervention into these community settings, this proposal aims to enhance individual health outcomes and support healthy nutrition among older adults. This approach prioritizes an evidence based, responsive, community-based solution to the increasingly complex health needs of this expanding population, fostering healthier aging and more resilient communities. The purpose of this study is to examine the feasibility of a CVD risk reduction program targeted to improve nutrition and self-management of chronic cardiovascular conditions among older adults participating in congregate meal programs offered at community senior centers. The specific aim is to examine the feasibility of a CVD risk reduction program (CAN-DO) delivered to older adults participating in a congregate meal program. The rates of recruitment, retention, acceptance, and participant satisfaction of the intervention protocol, and processes for training and engaging a CHW for intervention delivery in preparation for a larger, fully powered trial will be assessed. Secondary aims will include health outcomes that indicate promise of the intervention's potential effect on cardiovascular risk reduction and will include measurement of hemoglobin A1c, lipid panel, blood pressure, body anthropometrics and nutritional intake (food frequency questionnaire, diet quality with HEI (healthy eating index) scoring, Veggie Meter scores as an indicator of adherence to intervention). These risk factor outcomes will be measured at baseline, 18 weeks (intermediate feasibility) and at 30 weeks to evaluate long term feasibility of the project among older adults participating in a congregate meal program.

Interventions

BEHAVIORALCAN-DO

usual programing offered as part of the congregate meal program plus 18 weekly group education sessions related to CVD risk reduction and nutrition.

Sponsors

Martha Biddle
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* community dining site with a minimum of 20 or more congregate meal program participants. * ≥ 60 years of age * registered meal program participant at the community dining site * speak English

Exclusion criteria

* less than 60 years of age * don't participate in baseline measurements

Design outcomes

Primary

MeasureTime frameDescription
Proportion of eligible individuals who enroll in the study6 monthsFeasibility will be measured by recruitment rates, the proportion of eligible individuals who enroll during the time required to reach enrollment targets.
Number of participants enrolled at each timepointBaseline, week 18, and week 30Retention rates at each time point will be quantified
Change in Veggie Meter scoresBaseline, week 18, and week 30The participant's adherence to the intervention will be assessed using the veggie meter, which uses light reflectance spectroscopy to provide an estimated skin carotenoid composite score. Score ranges from 0 to 800, with higher scores associated with greater fruit and vegetable intake.
Participant Satisfaction with intervention30 weeksOverall satisfaction will be measured using a likert type scale 0-5, with a higher score equating to greater satisfaction, satisfaction will include measurement of frequency, duration and timing of intervention, total scores will range from 0-15, a mean score for overall satisfaction will be reported

Secondary

MeasureTime frameDescription
Change in waist circumferencebaseline, 18 and 30 weeksWaist circumference will be measured using a cloth measuring tape at the point of the umbilicus with minimal clothing
Change in hemoglobin A1cbaseline, 18 weeks and 30 weeksHemoglobin A1c will be measured with the Bayer HgA1c point of care machine
Change in diet quality using an HEI index scorebaseline, 18 and 30 weeksDiet quality will be assessed using a Frequency Questionnaire (FFQ). The NDSR FFQ provides the data that allows for calculating the Healthy Eating Index. We will use the 2015 index rules. Healthy Eating Index (HEI) 2015 Score and individual component scores will be calculated from the FFQ according to the HEI-2015 guidelines to assess changes in overall diet quality and changes within each component. The range of scores for the Healthy Eating Index 2015 is 0-100. A higher score is considered better and represents meeting more of the recommended dietary guidelines
Change in total cholesterol per lipid panelBaseline, 18 and 30 weeksLipids will be measured using Cholestech LDX point of care machine using fingerstick non-fasting blood samples,
Change in systolic blood pressurebaseline, 18 and 30 weeksMeasurement of systolic blood pressure will be obtained using a digital BP machine
Change in diastolic blood pressurebaseline, 18 and 30 weeksMeasurement of diastolic blood pressure will be obtained using a digital BP machine

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026